Nutrition Guide

The Food Supplements Directive[13] requires that supplements be demonstrated to be safe, both in quantity and quality. Some vitamins are essential in small quantities but dangerous in large quantities, notably Vitamin A. Consequently, only those supplements that have been proven to be safe may be sold without prescription. In practice, however, there appears to be little risk to supplement users of experiencing adverse side effects due to excessive intakes of micronutrients.[14]

In Europe, it is also an established view that food supplements should not be labeled with drug claims but can bear health claims, although to a degree that differs from one member state to the other.

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Legal challenge

The dietary supplements industry in the UK, one of the 27 countries in the European Union, strongly opposed the Directive. In addition, a large number of consumers throughout Europe, including over one million in the UK, and many doctors and scientists, have signed petitions against what are viewed by the petitioners as unjustified restrictions of consumer choice.[15] In 2004, along with two British trade associations, the Alliance for Natural Health had a legal challenge to the European Union’s Food Supplements Directive[16] referred to the European Court of Justice by the High Court in London.[17] Although the European Court of Justice’s Advocate General subsequently said that the EU’s plan to tighten rules on the sale of vitamins and food supplements should be scrapped,[18] he was eventually overruled by the European Court, which decided that the measures in question were necessary and appropriate for the purpose of protecting public health. ANH, however, interpreted the ban as applying only to synthetically produced supplements - and not to vitamins and minerals normally found in or consumed as part of the diet.[19] Nevertheless, the European judges did acknowledge the Advocate General’s concerns, stating that there must be clear procedures to allow substances to be added to the permitted list based on scientific evidence. They also said that any refusal to add a product to the list must be open to challenge in the courts.[20]

Battery is a brand of energy drink by Oy Sinebrychoff Ab of Finland and the market leader of energy drinks in Finland.

United States

In the United States, a dietary supplement is defined under the Dietary Supplement Health and Education Act of 1994[2] (DSHEA) as a product that is intended to supplement the diet and contains any of the following dietary ingredients:
a vitamin
a mineral
an herb or other botanical (excluding tobacco)
an amino acid
a dietary substance for use by people to supplement the diet by increasing the total dietary intake, or
a concentrate, metabolite, constituent, extract, or combination of any of the above

Furthermore, it must also conform to the following criteria:
intended for ingestion in pill, capsule, tablet, powder or liquid form
not represented for use as a conventional food or as the sole item of a meal or diet
labeled as a “dietary supplement”

The hormones DHEA (a steroid), pregnenolone (also a steroid) and the pineal hormone melatonin are marketed as dietary supplements in the US.[3][4]

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Regulation

Pursuant to the DSHEA, the Food and Drug Administration (FDA) regulates dietary supplements as foods, and not as drugs. While pharmaceutical companies are required to prove the safety or effectiveness of their products, until recently supplement manufacturers were not, and the FDA could take action only after a dietary supplement had been proven harmful.[5] However, new FDA rules will, by June 2010, ensure that all production of dietary supplements must comply with current good manufacturing practices, and be manufactured with “controls that result in a consistent product free of contamination, with accurate labeling.”[6] In addition, the industry is now required to report to the FDA “all serious dietary supplement related adverse events.”

The DSHEA, passed in 1994, was the subject of lobbying efforts by the manufacturers of dietary supplements.[7][8] At the time of its passage DSHEA received strong support from consumer grassroots organizations, and Members of Congress. In recognition of this, President Bill Clinton, on signing DSHEA into law, stated that “After several years of intense efforts, manufacturers, experts in nutrition, and legislators, acting in a conscientious alliance with consumers at the grassroots level, have moved successfully to bring common sense to the treatment of dietary supplements under regulation and law.” He also noted that the passage of DSHEA “speaks to the diligence with which an unofficial army of nutritionally conscious people worked democratically to change the laws in an area deeply important to them” and that “In an era of greater consciousness among people about the impact of what they eat on how they live, indeed, how long they live, it is appropriate that we have finally reformed the way Government treats consumers and these supplements in a way that encourages good health.”[9]

Popular support may have been based on a misunderstanding of the situation after the deregulation of the supplement industry. A large survey by the AARP, for example, found that 77% of respondents (including both users and non-users of supplements) believed that the federal government should review the safety of dietary supplements and approve them before they can be marketed to consumers.[10] In an October 2002 nationwide Harris poll, 59% of respondents believed that supplements had to be approved by a government agency before they could be marketed; 68% believed that supplements had to list potential side effects on their labels; and 55% believed that supplement labels could not make claims of safety without scientific evidence. All of these beliefs were incorrect as a result of provisions of the DSHEA.[11]

A 2001 study, published in Archives of Internal Medicine, found broad public support for greater governmental regulation of dietary supplements than was currently permitted by DSHEA. The researchers found that a majority of Americans supported pre-marketing approval by the FDA, increased oversight of harmful supplements, and greater scrutiny of the truthfulness of supplement label claims.[12]

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Permissible claims

The claims that a dietary supplement makes are essential to its classification. If a dietary supplement claims to cure, mitigate, or treat a disease, it would be considered to be an unauthorized new drug and in violation of the applicable regulations and statutes. As the FDA states it in a response to this question in a FAQ:

Is it legal to market a dietary supplement product as a treatment or cure for a specific disease or condition?
No, a product sold as a dietary supplement and promoted on its label or in labeling* as a treatment, prevention or cure for a specific disease or condition would be considered an unapproved–and thus illegal–drug. To maintain the product’s status as a dietary supplement, the label and labeling must be consistent with the provisions in the Dietary Supplement Health and Education Act (DSHEA) of 1994.
*Labeling refers to the label as well as accompanying material that is used by a manufacturer to promote and market a specific product.

Dietary supplements are permitted to make structure/function claims. These are broad claims that the product can support the structure or function of the body (e.g., “glucosamine helps support healthy joints”, “the hormone melatonin helps establish normal sleep patterns”). The FDA must be notified of these claims within 30 days of their first use, and there is a requirement that these claims be substantiated.

Other claims that required approval from FDA include health claims and qualified health claims. Health claims are permitted to be made if they meet the requirements for the claims found in the applicable regulations. Qualified health claims can be made through a petition process, including scientific information, if FDA has not approved a prior petition.

Carbohydrates (from ‘hydrates of carbon’) or saccharides (Greek ????????, sákcharon, meaning “sugar”) are the most abundant of the four major classes of biomolecules. They fill numerous roles in living things, such as the storage and transport of energy (starch, glycogen) and structural components (cellulose in plants, chitin in animals). Additionally, carbohydrates and their derivatives play major roles in the working process of the immune system, fertilization, pathogenesis, blood clotting, and development.[1]

Chemically, carbohydrates are simple organic compounds that are aldehydes or ketones with many hydroxyl groups added, usually one on each carbon atom that is not part of the aldehyde or ketone functional group. The basic carbohydrate units are called monosaccharides, such as glucose, galactose, and fructose. The general stoichiometric formula of an unmodified monosaccharide is (C·H2O)n, where n is any number of three or greater; however, the use of this word does not follow this exact definition and many molecules with formulae that differ slightly from this are still called carbohydrates, and others that possess formulae agreeing with this general rule are not called carbohydrates (eg formaldehyde).[2]

Monosaccharides can be linked together into what are called polysaccharides (or oligosaccharides) in almost limitless ways. Many carbohydrates contain one or more modified monosaccharide units that have had one or more groups replaced or removed. For example, deoxyribose, a component of DNA, is a modified version of ribose; chitin is composed of repeating units of N-acetylglucosamine, a nitrogen-containing form of glucose. The names of carbohydrates often end in the suffix -ose.

A dietary supplement, also known as food supplement or nutritional supplement, is a preparation intended to supply nutrients, such as vitamins, minerals, fatty acids or amino acids, that are missing or are not consumed in sufficient quantity in a person’s diet. Some countries define dietary supplements as foods, while in others they are defined as drugs.

Supplements containing vitamins or dietary minerals are recognised by the Codex Alimentarius Commission, the United Nations’ highest authority on food standards, as a category of food.[1]

Bacchus F contains the following ingredients:[2]

Water, high fructose corn syrup, sugar, taurine, inositol, guaraná extract, royal jelly, nicotinamide, pyridoxine hcl, riboflavin sodium phosphate, thiamine nitrate preserved with sodium benzoate, ethanol, citric acid anhydrous, sorbitol, apple juice, sodium chloride, natural essences(orange, pineapple, strawberry), artificial flavors.

The supplement played a large role in the controversial non-fiction book Game of Shadows by Mark Fainaru-Wada and Lance Williams. It is important to note that “of the 57 Western Washington University football players who signed up for the study, 30 quit. By the end, only a dozen players were using ZMA while 15 took the placebo.” (Game Of Shadows 46)[5]

A 1999 study was undertaken on NCAA Football players during an 8 week spring training program. The control group was told to cease taking any nutritional supplements. Those who took the ZMA tablets showed greater increases in muscle strength, free testosterone levels, and IGF-1 levels.[3] This study was funded by SNAC Systems Inc. (the patent holders) and one of the study’s authors (Victor Conte) has equity in this company.

Another study in 2004 conducted jointly by the Exercise & Sport Nutrition Lab of Baylor University, IMAGINutrition, and the Journal of the International Society of Sports Nutrition, found that ZMA has no effect on strength, hormone levels, or anaerobic capacity.[4]

Bacchus-F (Hangul:???-??) is a non-carbonated Korean energy drink. It is manufactured by the Dong-A Corporation; it is also distributed in the United States under the Dong-A America Corporation in a 3.3 oz glass bottle (approximately 1/3 the size of a Red Bull). Dong-A Pharmaceutical, a branch of the Dong-A Corporation, also manufactures Bacchus-D, one of the three original energy drinks in the world[1]. Although Bacchus-F has been popular in South Korea for many years, it has recently risen to prominence in North American culture alongside other popular energy drinks consumed in combination with alcohol, such as Vodka-Red Bull. The most common form of consumption is the “Bacchus Bomb,” which is produced by pouring 3.3 oz of Bacchus-F into a cup and subsequently dropping a shot glass filled with vodka into the cup, with the resulting mixture being consumed as rapidly as possible.

ZMA (Zinc monomethionine aspartate and Magnesium Aspartate) is a supplement used by bodybuilders and athletes. It was developed by Victor Conte (founder of BALCO Laboratories in Burlingame, California) and is a combination of zinc, magnesium and vitamin B6. The formula is “patent pending” and the name “ZMA” trademarked by SNAC System Inc, also founded by Victor Conte. ZMA is claimed to raise testosterone and IGF-1 levels which may aid in gaining muscle size and strength.

ZMA is a combination of two minerals, zinc and magnesium, and Vitamin B-6 or pyridoxine. All three of these compounds are important in biological processes, and while studies have shown that most Americans get enough zinc and Vitamin B6,[1] more than 50% are deficient in magnesium.[2]

An increase in exercise can lead to the loss of vitamins and minerals making it particularly important for bodybuilding due to the blood sugar level rises and urination increases, increasing the loss of magnesium, zinc, B12, B6, folic acid, and many other nutrients. Although drinking water re-hydrates an athlete, fruit juice, sports drinks or foods high in water such as vegetables are needed to replenish water-soluble nutrients.

The proportion of ingredients generally used in products is 20-30 mg Zinc, 400-500 mg Magnesium and ~10mg B6. According to the label directions, ZMA should be taken before bed on an empty stomach (2 hours after eating your last meal and at least 30 minutes prior to any other supplements). The product should not be taken with calcium (cheese,milk,etc.), the reason being that calcium blocks the absorption of zinc.